E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011401 |
E.1.2 | Term | Crohn's disease |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate the efficacy and safety of two doses of adalimumab, 160 mg at Week 0 and 80 mg at Week 2 and 80 mg at Week 0 and 40 mg at Week 2 for the induction of clinical remission in Japanese subjects with moderate to severe Crohn's disease and to assess the pharmacokinetics of adalimumab and the development of antibodies against adalimumab following sc injections of adalimumab. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Crohn's Disease Activity Index (CDAI) score of >= 220 and <= 450.
•If subjects have previously been administered infliximab, subjects who discontinued use due to a loss of response or intolerance to infliximab therapy.
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E.4 | Principal exclusion criteria |
•Ulcerative colitis or indeterminate colitis
•History of cancer, lymphoma, leukemia or lymphoproliferative disease, active tuberculosis (TB), or Human immunodeficiency virus (HIV)
•Body weight is below 30 kg
•Surgical bowel resections within the past 6 months
•Females who are pregnant or breast-feeding or considering becoming pregnant during the study |
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E.5 End points |
E.5.1 | Primary end point(s) |
The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Proportion of subjects in each treatment group in clinical remission (CDAI < 150) at Week 2, Week 6 and Week 8.
2. Proportion of subjects in each treatment group with a clinical response (CDAI decrease of > 70 compared to Baseline) at Week 2, Week 4, Week 6, and Week 8.
3. Proportion of subjects in each treatment group with a clinical response (CDAI decrease of > 100 compared to Baseline) at Week 2, Week 4, Week 6 and Week 8.
4. Changes from Baseline in CDAI scores in each treatment group at Week 2, Week 4, Week 6, and Week 8.
5. Changes from Baseline in IOIBD scores in each treatment group at Week 2, Week 4, Week 6, and Week 8.
6. Changes from Baseline in IBDQ scores in each treatment group at Week 4, and Week 8.
7. Changes from Baseline in outcomes variables in the SF-36 Health Survey in each treatment group at Week 4, and Week 8. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |